Multiple MyelomaMYELOPTICNCT05786105
Optical Genome Mapping in Characterization of Multiple Myeloma
An observational study of Multiple Myeloma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
The current cytogenetic characterization of Multiple Myeloma (including chromosome and gene abnormalities identification in abnormal plasma cells) encounters some limitations. Indeed current techniques only enable to analyze a limited numbers of predefined abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bone Marrow samples collection
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2023to 21 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of multiple myeloma not previously treated (except with corticosteroids) and requiring treatment initiation (presence of CRAB criteria).
Who may be able to join
- Age ≥ 18 years
- Non previously treated Multiple Myeloma (criteria from the International Myeloma Working Group)
- Presence of CRAB criteria (Calcium Renal Anemia Bone : Calcemia > 2.75 mmol/l or > 0.25 mmol/l higher than the Upper Limit of Normal ; serum creatinine > 173 μmol/l or creatinine clearance < 40ml per minute attributed to myeloma ; anemia with hemoglobin value < 10g/dl or more than 2g/dl below the Lower Limit of Normal, bone lesions with osteolytic lesions or osteoporotic vertebral collapses attributed to myeloma)
Who cannot join
- Opposition of the patient
- Failure of myelogram
- Previous treatment of multiple myeloma (except with corticosteroids)
- Failure of FISH
- Minor or patients placed under guardianship or supervision
- Patients deprived of liberty
Show all 9Show fewer
- Patients placed under judicial protection
- Patients that are not able to express their consent
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The current cytogenetic characterization of Multiple Myeloma (including chromosome and gene abnormalities identification in abnormal plasma cells) encounters some limitations. Indeed current techniques only enable to analyze a limited numbers of predefined abnormalities. New tools that will allow for characterization of abnormalities involved in multiple myeloma development are thus required. The interest of Optical Genome Mapping has already been demonstrated in other hematological diseases. The present study aims at validating Optical Genome Mapping in genetic abnormalities identification for patients with Multiple Myeloma (MM).
Read the detailed description
For this study, supplementary samples will be collected during bone marrow biopsy performed at MM diagnosis. These will be used for CD138+ Plasma Cell Isolation and sent to GENTYANE (GEnoTYpage and sequencing in AuvergNE) platform in Clermont-Ferrand for Optical Genome Mapping.
- Conditions
- Multiple Myeloma
- Being tested
- Bone Marrow samples collection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow samples collectionOther
Bone Marrow samples collection - one ethylenediaminetetraacetic acid (EDTA) tube - for Optical Genome Mapping
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the use of Optical Genome Mapping in Multiple Myeloma characterization
Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)
Measured: At MM diagnosis
Secondary outcomes (1)
Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma
Numbers of genetic abnormalities that are detected with Optical Genome Mapping but not detected with FISH
Measured: At MM diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start21 Apr 2023
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- GENTYANE (GEnoTYpage and sequencing in AuvergNE), Hôpitaux Universitaires de Strasbourg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786105
- Sponsor's protocol ID
- 2022-014
- Other IDs
- 2022-A02286-37
- Acronym
- MYELOPTIC
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.
PubMed 25439696
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Genome Mapping in Characterization of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05786105
- Acronym / sponsor ID
- MYELOPTIC / 2022-014
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- GENTYANE (GEnoTYpage and sequencing in AuvergNE), Hôpitaux Universitaires de Strasbourg
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current cytogenetic characterization of Multiple Myeloma (including chromosome and gene abnormalities identification in abnormal plasma cells) encounters some limitations. Indeed current techniques only enable to analyze a limited numbers of predefined abnormalities. New tools that will allow for characterization of abnormalities involved in multiple myeloma development are thus required. The interest of Optical Genome Mapping has already been demonstrated in other hematological diseases. The present study aims at validating Optical Genome Mapping in genetic abnormalities identification for patients with Multiple Myeloma (MM).
Detailed description
For this study, supplementary samples will be collected during bone marrow biopsy performed at MM diagnosis. These will be used for CD138+ Plasma Cell Isolation and sent to GENTYANE (GEnoTYpage and sequencing in AuvergNE) platform in Clermont-Ferrand for Optical Genome Mapping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of multiple myeloma not previously treated (except with corticosteroids) and requiring treatment initiation (presence of CRAB criteria).
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Non previously treated Multiple Myeloma (criteria from the International Myeloma Working Group)
- Presence of CRAB criteria (Calcium Renal Anemia Bone : Calcemia > 2.75 mmol/l or > 0.25 mmol/l higher than the Upper Limit of Normal ; serum creatinine > 173 μmol/l or creatinine clearance < 40ml per minute attributed to myeloma ; anemia with hemoglobin value < 10g/dl or more than 2g/dl below the Lower Limit of Normal, bone lesions with osteolytic lesions or osteoporotic vertebral collapses attributed to myeloma)
Key exclusion criteria (9 listed)
- Opposition of the patient
- Failure of myelogram
- Previous treatment of multiple myeloma (except with corticosteroids)
- Failure of FISH
- Minor or patients placed under guardianship or supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow samples collectionBone Marrow samples collection - one ethylenediaminetetraacetic acid (EDTA) tube - for Optical Genome Mapping | Other | – |
Primary outcome
Validate the use of Optical Genome Mapping in Multiple Myeloma characterization
Time frame: At MM diagnosis
Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)
1 secondary outcome
Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma
Time frame: At MM diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 25439696Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the use of Optical Genome Mapping in Multiple Myeloma characterization (time frame: At MM diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.